Genesys Spine TiLock System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K103671 ↗

FDA Product Code

NKB

Device Class

Class II

Regulation

21 CFR Part 888.3070

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Genesys Spine Anterior Buttress Plate System

  Class II

  FDA 510(k) K133911 Active Cleared 3 Sep 2014

• Genesys Spine Apache Interbody Fusion System

  Class II

  FDA 510(k) K153123 Active Cleared 26 Apr 2016

• Genesys Spine TiLock Cortical Spinal System

  Class II

  FDA 510(k) K161914 Active Cleared 9 Aug 2016

• TiLock2 Spinal System

  Class II

  FDA 510(k) K152039 Active Cleared 28 Oct 2015

• Genesys Spine Sacroiliac Joint Fusion System

  Class II

  FDA 510(k) K191748 Active Cleared 26 Sep 2019

• Genesys Spine Interbody Fusion System

  Class II

  FDA 510(k) K103034 Active Cleared 10 Dec 2010

See all devices from Genesys Spine →

• What is the Genesys Spine TiLock System used for?

  The Genesys Spine TiLock System is designed for posterior orthopedic applications to address spinal instability or deformity during open surgical procedures. Its modular components—including polyaxial screws (solid and cannulated), tulip heads, lock screws, and rods—allow surgeons to create custom stabilization solutions tailored to specific anatomical needs. This flexibility ensures precise alignment and fixation, supporting long-term spinal stability.

• How is the TiLock System supplied and intended for use?

  The TiLock System is supplied sterile and intended for single-use only. This ensures patient safety by minimizing infection risks and maintaining consistent sterility throughout the surgical procedure. The modular design also allows for intraoperative adjustments, enabling surgeons to adapt the fixation to the patient’s anatomy during surgery.

• Is the TiLock System reusable, or is it meant for one-time use?

  The TiLock System is explicitly designed for single-use only. This is reflected in its sterile packaging and FDA clearance (K103671) as a substantially equivalent orthopedic device. Reuse is not recommended due to potential compromises in sterility, structural integrity, or biocompatibility over repeated use.

• What sizes and configurations are available for the TiLock System?

  The TiLock System offers multiple configurations, including polyaxial screws (both solid and cannulated), tulip heads, lock screws, and rods in varying lengths and diameters. These components are engineered to accommodate different anatomical requirements, ensuring compatibility with standard spinal fixation techniques. The modular nature allows for customization based on surgical needs, such as pedicle screw placement or rod contouring.

• How should the TiLock System be stored before use?

  The TiLock System should be stored in its original sterile packaging to preserve sterility until use. It is critical to avoid exposure to moisture, extreme temperatures, or contamination. If the packaging is compromised, the system should not be used, as this could compromise patient safety. Always follow manufacturer guidelines for storage conditions to maintain device integrity.